The U.S. FDA granted accelerated approval to Amgen Inc.’s Imdelltra (tarlatamab) for treating adults with extensive-stage small-cell lung cancer with disease progression on or after platinum-based chemotherapy. The approval may well lead the drug to blockbuster status while bolstering the company’s cancer portfolio.
As investment in Asia biohubs continues into 2024, Merck KGaA’s Milliporesigma is the latest to drop more than €300 million (US$328 million) into a new bioprocessing production center in Daejeon, South Korea.
The week began with PDUFA-delaying news for Regeneron Pharmaceuticals Inc. The company said it received two complete response letters (CRLs) from the U.S. FDA regarding the priority BLA for its bispecific antibody to treat lymphoma, odronextamab.
As investment in Asia biohubs continues into 2024, Merck KGaA’s Milliporesigma is the latest to drop more than €300 million (US$328 million) into a new bioprocessing production center in Daejeon, South Korea. Other big pharmas, including Switzerland’s Novartis AG, Denmark’s Novo Nordisk A/S and China’s Wuxi Biologics (Cayman) Inc., are also making multimillion-dollar investments in the Asia-Pacific region, according to company announcements made in March 2024.
Previous research has shown that the three isoforms of transforming growth factor β (TGF-β) have distinct cellular expression patterns, with TGF-β2 and TGF-β3 expression being specifically elevated in human fibrotic lung and liver tissue. Since pan-TGF-β inhibition had proven to be toxic for chronic use, in recent work, researchers from Genentech Inc. aimed to assess whether specifically targeting one of the TGF-β isoforms could represent a novel therapeutic option for patients with chronic fibrotic disorders.
Genedit Inc. has entered into a multiyear collaboration and license agreement with Genentech Inc., a member of the Roche Group, to use Genedit's Nanogalaxy platform to discover and develop novel hydrophilic nanoparticles to deliver Genentech's nucleic acid-based medicines for treatment of autoimmune disease.
Getting revolutionary genetic medicines to the right place is the reason Genedit Inc. was created, and CEO Kunwoo Lee pared down the mission in one word. “Delivery, delivery, delivery,” Lee told BioWorld in describing the goal of Genedit’s Nanogalaxy platform that is focused on delivering genetic medicines into select tissue. Privately held Genedit will work with Genentech to find and develop hydrophilic nanoparticles for creating nucleic acid-based drugs to treat autoimmune diseases. Genedit is getting $15 million up front in a new deal that could bring in up to $629 million in near-term, preclinical and clinical development, commercial and net sales milestones.
Respiratory imaging technology company 4Dmedical Ltd. is acquiring Imbio LLC for $45 million to create a comprehensive portfolio of cardiothoracic imaging technologies. The news comes on the heels of U.S. FDA clearance of 4Dmedical’s computed tomography lung ventilation analysis software in November 2023.
The oral drug inavolisib, when added to two other therapies, significantly improved progression-free survival in the first-line phase III treatment of advanced hormone receptor-positive, HER2-negative breast cancer in which patients have a PIK3CA mutation.
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